Introduction Pharmacovigilance (PV) systems to monitor drug and vaccine safety are often inadequate in sub-Saharan
Africa. In Malawi, a PV enhancement initiative was introduced to address major barriers to PV.
Objective The objective of this initiative was to improve reporting of adverse events (A...Es) by strengthening passive safety
surveillance via PV training and mentoring of local PV stakeholders and healthcare providers (HCPs) at their own healthcare
facilities (HCFs).
Methods An 18-month PV training and mentoring programme was implemented in collaboration with national stakeholders,
and in partnership with the Ministry of Health, GSK and PATH. Two-day training was provided to Expanded Programme on
Immunisation coordinators, identified as responsible for AE reporting, and four National Regulatory Authority representa-
tives. Abridged PV training and mentoring were provided regularly to HCPs. Support was given in upgrading the national
PV system. Key performance indicators included the number of AEs reported, transmission of AE forms, completeness of
reports, serious AEs reported and timeliness of recording into VigiFlow.
Results In 18 months, 443 HCPs at 61 HCFs were trained. The number of reported AEs increased from 22 (January 2000 to
October 2016) to 228 (November 2016 to May 2018), enabling Malawi to become a member of the World Health Organization
Programme for International Drug Monitoring. Most (98%) AE report forms contained mandatory information on reporter,
event, patient and product, but under 1% were transmitted to the national PV office within 48 h.
Conclusion Regular PV training and mentoring of HCPs were effective in enhancing passive safety surveillance in Malawi,
but the transmission of reports to the national PV centre requires further improvement.
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with recommended essential medicines for common diseases in patients in Stockholm County Council (Healthcare Region), Sweden
The new, all oral, 20-month MDR-TB regimens range from US $1,600* (using bedaquiline and linezolid for 6 months and levofloxacin as the fluoroquinolone) to US $2,100* (using linezolid for 12 months and moxifloxacin as the fluoroquinolone.
Doc. No.: INS/GDL/001-(Annexes)
Harm reduction: evidence, impacts and challenges
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ATLAS on substance use (2010) — Resources for the prevention and treatment of substance use disorders
Accessed: 14.03.2019
ATLAS on substance use (2010) — Resources for the prevention and treatment of substance use disorders
Accessed: 14.03.2019
Handbook of Foodborne Pathogenic Microorganisms and Natural Toxins
A summary of the national drug situation